# FDA 483 - Community Fertility Specialty Care - January 11, 2024

Source: https://www.globalkeysolutions.net/records/483/community-fertility-specialty-care/ad04e738-2cad-4753-a080-fd81a3a9ee90

> FDA 483 for Community Fertility Specialty Care on January 11, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Community Fertility Specialty Care
- Inspection Date: 2024-01-11
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Community Fertility Specialty Care in Indianapolis, IN, revealed significant deficiencies in donor eligibility determination and communicable disease testing for oocyte donors. The firm failed to test donors for relevant communicable diseases like West Nile Virus and Hepatitis B, and did not maintain proper documentation for donor eligibility. Additionally, the facility's procedures were inadequate to ensure compliance with required donor screening tests.

## Related Officers

- [Lesley Mae P. Lutao](https://www.globalkeysolutions.net/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.globalkeysolutions.net/companies/community-fertility-specialty-care/0b267058-d5cd-429d-9838-948e4b51d4c6

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0